DCB angioplasty vs DES implantation: Which is better in coronary stent restenosis?
Drug-coated balloon (DCB) angioplasty and repeat stenting with drug-eluting stent (DES) show comparable safety and effectiveness in the treatment of patients with bare-metal stent (BMS) coronary in-stent restenosis (ISR) at 3 years, according to a study.
On the other hand, DCB angioplasty is significantly less effective than repeat DES implantations in the treatment of patients with DES-ISR and correlated with a nonsignificant decrease in the composite of all-cause death, myocardial infarction, or target lesion thrombosis at 3-year follow-up.
The investigators conducted a pooled analysis of individual patient data from all 10 existing randomized clinical trials comparing DCB angioplasty with repeat DES implantation for the treatment of coronary ISR. Patients were stratified in the prespecified analysis according to BMS- vs DES-ISR and treatment assigned.
Target lesion revascularization (TLR) was the primary efficacy endpoint, while the primary safety endpoint was a composite of all-cause death, myocardial infarction, or target lesion thrombosis at 3 years. Mixed-effects Cox models were used for the primary analysis, accounting for the trial of origin.
Overall, 710 patients with BMS-ISR (722 lesions) and 1,248 with DES-ISR (1,377 lesions) were included in the analysis. No significant difference was seen between treatments in patients with BMS-ISR in terms of primary efficacy (9.2 percent vs 10.2 percent; hazard ratio [HR], 0.83, 95 percent confidence interval [CI], 0.51–1.37) and safety endpoints (8.7 vs 7.5 percent; HR, 1.13, 95 percent CI, 0.65–1.96). Results were consistent in secondary analyses.
In patients with DES-ISR, DCB angioplasty showed a higher risk of the primary efficacy endpoint than repeat DES implantation (20.3 percent vs 13.4 percent; HR, 1.58, 95 percent CI, 1.16–2.13) and a numerically lower risk of the primary safety endpoint (9.5 percent vs 13.3 percent; HR, 0.69, 95 percent CI, 0.47–1.00). Secondary analyses results were consistent.
Regardless of the treatment used, TLR risk was lower in BMS- vs DES-ISR (9.7 percent vs 17.0 percent; HR, 0.56, 95 percent CI, 0.42–0.74). On the other hand, no statistical difference was seen between ISR types in terms of safety.
“Overall, DES-ISR is associated with higher rates of treatment failure and similar safety compared with BMS-ISR,” the investigators said.